Alvotech partners with Lotte Biologics for US biosimilar manufacturing
Alvotech, a Reykjavik, Iceland-based biotechnology company focused on biosimilar medicines, has entered a long-term manufacturing agreement with Seoul-based Lotte Biologics to produce drug substance for multiple antibody biosimilars at its Syracuse, New York facility.
The Syracuse site has 40,000 liters of bioreactor capacity for biologics manufacturing, along with on-site process development and quality control capabilities. According to the companies, the facility has commercial biologics manufacturing experience and recently completed an unannounced U.S. Food and Drug Administration inspection with no observations.
The agreement will expand Alvotech’s U.S.-based manufacturing network and complement its existing manufacturing partnerships and internal development and manufacturing capabilities. The companies said the collaboration could expand over time to support additional products.
“Alvotech has one of the most comprehensive, internally developed product portfolios in the industry,” Lisa Graver, CEO of Alvotech, said in a statement. “With the expansion of our global manufacturing network, we will have sufficient capacity to meet demand for our pipeline for the next ten years.”
Commercial manufacturing will be subject to successful technology transfer, manufacturing qualification, and applicable regulatory approvals.
The agreement adds another U.S. manufacturing commitment by a foreign-based pharmaceutical company or CDMO. Earlier this month, Portugal-based Hovione announced a $35 million investment in a continuous tableting line at its East Windsor, New Jersey, campus, extending its continuous tableting capabilities to the U.S. Spain-based Esteve CDMO also announced an additional $17.5 million for its Morton Grove, Illinois, facility, bringing its total announced investment at the site to $33 million and adding reactor capacity and containment capabilities.
In September, Switzerland-based CordenPharma broke ground on a more than $200 million expansion in North Augusta, South Carolina, adding 68,000 square feet of commercial manufacturing space and expanding peptide synthesis capacity.
Lotte Biologics is simultaneously expanding its manufacturing network in South Korea. Its Songdo Bio Campus Plant 1 in Incheon has 120,000 liters of bioreactor capacity and is designed for large-scale antibody manufacturing, with commissioning and production-system validation scheduled for the second half of 2026. The CDMO plans to invest $1 billion in the Songdo campus and ultimately build three manufacturing plants there by 2030.
Lotte’s Syracuse operations and Songdo Bio Campus will provide dual-site manufacturing support as its partnership with Alvotech develops.
“Alvotech’s expertise in biosimilar development, combined with Lotte Biologics’ manufacturing capabilities, creates a strong foundation for this collaboration,” James Park, CEO of Lotte Biologics, said in a statement. “With our Syracuse operations and the completion of our Songdo Bio Campus, we are committed to providing flexible, dual-site manufacturing support as the partnership grows.”
